Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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BLOOD PUMPS
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS
[0001] This application claims priority to U.S. Provisional
Patent Application No.
62/943,062, filed on December 3, 2019, and to U.S. Provisional Patent
Application No.
62/947,740, filed on December 13, 2019, the entire contents of each of which
are hereby
incorporated by reference herein in their entirety and for all purposes. Any
and all
applications for which a foreign or domestic priority claim is identified in
the Application
Data Sheet as filed with the present application are hereby incorporated by
reference under
37 C.F.R. 1.57.
BACKGROUND
Field
[0002] This invention relates to improved blood pumps.
Description of the Related Art
[0003] In the field of cardiac assist devices and
mechanical circulatory support,
blood pumps are used to support the heart in circulating blood through the
body. Implantable
impeller pumps make up one common class of blood pumps used.
[0004] Impeller pumps use bearings to connect the impeller
to the rest of the
pump in a way that constrains the impeller both radially and axially, but
leaves it free to
rotate. Sleeve bearings (or journal bearings) are a common type of bearing
that provide radial
confinement. Cone bearings provide both axial and radial confinement. Both
sleeve and cone
bearings also have improved pressure-velocity characteristics (due to their
two-dimensional
bearing interfaces), in contrast to bearings that rely on point or line
contact.
[0005] Blood pumps also typically include structure that
provides torque coupling
between the motor and the pump impeller. Common variations of this design
element are
direct torque coupling and magnetic torque coupling.
SUMMARY
[0006] There remains a continuing need for improved blood
pumps.
[0007] One major difficulty with blood pumps is sensitivity
of blood to the
conditions created by the pump. Common problems include blood clots and
hemolysis,
especially with bearings that have areas where blood can stagnate and clot.
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[00081 Key factors in the design and evaluation of blood
pump comprise:
enhancing fluid flow to the bearing regions, enhancing fluid flow from the
bearing regions,
creating lubricating fluid layers in the bearing regions, maintaining the
pressure-volume
characteristics of the bearing interfaces within favorable ranges, and
minimizing forces on
the blood that can lead to thrombosis or hemolysis.
[0009] In one embodiment, a modular bearing system for
blood pumps is
provided that enables different combinations of bearing design elements with
unique and
novel advantages. A first bearing is a sleeve bearing (or equivalently, a
journal bearing)
uniquely designed to allow flow through the pump with minimal obstruction. The
other is a
cone bearing. In some embodiments, one or more of these bearing designs may be
used. In
other embodiments, either bearing design may be used with additional bearing
design(s). In
other embodiments, the two bearing designs may be used together in a
configuration that
provides additional benefits.
[0010] The sleeve bearing may have a modified geometry for
reduced
thrombosis. Various low thrombosis sleeve geometries arc considered. The
sleeve bearings
may contain added features (e.g. a thrust ring) that provide some degree of
axial confinement
as well as radial confinement.
[0011] The cone bearings described in this disclosure have
modified geometries
that promote full washing of the bearing surfaces by blood. The full washing
of the bearing
surfaces may be promoted by enhanced sourcing of blood to the bearing region,
enhanced
removal of blood from the bearing region, or some combination of these.
[0012] The sleeve bearing and the cone bearing may have
certain features that
support their combined use and offer unique advantages arising from these
combinations.
[0013] In several embodiments, a blood flow assist system
is disclosed. In some
embodiments, the system consists essentially of an impeller assembly
comprising a rotor
assembly and an impeller coupled with the rotor assembly, the rotor assembly
comprising a
first curved bearing surface (e.g., a concave bearing surface), and a drive
unit proximal the
impeller assembly, the drive unit comprising a drive magnet and a drive
bearing between the
drive magnet and the impeller assembly, the drive bearing comprising a second
curved
bearing surface (e.g., a convex bearing surface) shaped to mate with (e.g.,
fit within) the first
curved bearing surface. In some embodiments, the first curved bearing surface
includes a
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fluid port. In some embodiments, the second bearing surface includes a void
(e.g., a central
hollow) and one or more channels extending radially outward from the void. The
void can
be in fluid communication with the fluid port so as to direct blood radially
outward along the
at least one channel. In some embodiments, the convex hearing surface has a
distal end
disposed distal of a proximal end of the rotor assembly. In some embodiments,
the convex
bearing surface comprises a plurality of distally-projecting segments, the
plurality of distally-
projecting segments spaced apart circumferentially to define at least one
channel between
adjacent segments.
[0014] In various illustrated embodiments, the rotor
assembly can include a
concave bearing surface, and the drive bearing can comprise a convex bearing
surface.
However, it should be appreciated that, in each of the embodiments disclosed
herein, the
rotor assembly may alternatively include a convex bearing surface and the
drive bearing can
comprise a concave bearing surface, with the convex bearing surface mating
with (e.g.,
fitting within) the concave bearing surface. Further, in embodiments in which
the rotor
assembly comprises the convex bearing surface, the plurality of segments may
extend
proximally (e.g., as opposed to distally-extending) and can be spaced apart
circumferentially
to define at least one channel between adjacent segments.
[0015] In some embodiments, the rotor assembly comprises an
impeller shaft and
a rotor magnet coupled to the impeller shaft, the impeller disposed on the
impeller shaft. In
some embodiments, the impeller assembly comprises a second impeller disposed
on the
impeller shaft spaced apart proximally from the impeller along the impeller
shaft. A flange
can extend non-parallel from a proximal end portion of the impeller shaft, the
second
impeller comprising a plurality of vanes disposed on a generally proximally-
facing surface of
the flange.
[0016] In some embodiments, the impeller is configured to
pump blood along a
first flow pathway along an exterior surface of the impeller, a majority of
the blood flowing
along the first flow pathway being directed along a longitudinal axis of the
blood flow assist
system. In some embodiments, the system includes a second flow pathway through
a lumen
of the impeller shaft, the second impeller configured to direct blood from the
second flow
pathway radially outward relative to the longitudinal axis. In some
embodiments, an angled
cavity extends inwardly and distally relative to the generally proximally-
facing surface of the
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flange. In some embodiments, the drive unit comprises a convex member sized to
fit within
the angled cavity. In some embodiments, the system includes a sleeve bearing
disposed
about the impeller shaft at a location distal the impeller. In some
embodiments, in a cross-
section taken perpendicular to an axis of rotation of the impeller, a support
surface of the
sleeve bearing is disposed about only a portion of a perimeter of the impeller
shaft at a
selected axial location, such that, when the impeller shaft is rotated about
the axis of rotation,
an exterior surface of the impeller shaft at the selected axial location is
cyclically exposed to
blood during operation of the blood flow assist system. In some embodiments,
the system
includes a pump housing, the impeller assembly disposed at least partially
within the pump
housing. In some embodiments, the pump housing includes an outlet, the outlet
disposed
proximal the impeller. In some embodiments, the second impeller is disposed
proximal a
distal end of the outlet. In some embodiments, the system includes a support
structure
coupled to or formed with the pump housing, the support structure comprising
struts
configured to contact a blood vessel wall to maintain spacing of the pump
housing from a
blood vessel wall in which the pump housing is disposed. In some embodiments,
the blood
flow assist system comprises a percutaneous pump configured for percutaneous
insertion to a
treatment location within a body of a patient. A motor can be mechanically
coupled with the
drive magnet and a power wire connected to the motor, the power wire extending
proximally
from the motor.
[0017] In several embodiments, a method of operating a
blood flow assist system
is disclosed. The method can include or consist essentially of percutaneously
delivering an
impeller assembly to a treatment location in a blood vessel of a patient, the
impeller assembly
comprising a rotor assembly and an impeller coupled with the rotor assembly,
the rotor
assembly comprising a concave bearing surface, the blood flow assist system
comprising a
drive unit proximal the impeller assembly, the drive unit comprising a drive
magnet and a
drive bearing between the drive magnet and the impeller assembly, the drive
bearing
comprising a convex bearing surface fitting within the concave bearing
surface, the convex
bearing surface comprising a plurality of distally-projecting segments, the
plurality of
distally-projecting segments spaced apart circumferentially to define at least
one channel
between adjacent segments; pumping blood longitudinally along a length of the
impeller
assembly and radially outwardly through the at least one channel; and removing
the impeller
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assembly from the patient. In some embodiments, the method includes directing
blood
radially outward between the drive unit and a second impeller disposed
proximal the
impeller, the drive unit having a distal end disposed distal of a proximal end
of the second
impeller. In some embodiments, the method includes providing relative motion
between the
impeller assembly and a sheath to cause a plurality of struts to self-expand
radially outwardly
to engage a wall of the blood vessel. In some embodiments, providing opposite
relative
motion between the impeller assembly and the sheath to cause the plurality of
struts to
collapse within the sheath. In some embodiments, the rotor assembly comprises
an impeller
shaft on which the impeller is disposed and a sleeve bearing disposed about
the impeller shaft
distal the impeller, the method comprising cyclically exposing an exterior
surface of the
impeller shaft to blood at a selected axial location. In some embodiments, the
method
includes supplying electrical current to a motor by way of a power wire, the
motor being
operably connected to the impeller assembly, the power wire extending outside
a body of the
patient.
[0018] In several embodiments, a method of manufacturing a
blood flow assist
system is disclosed. In some embodiments, the method includes or consists
essentially of
providing an impeller assembly comprising a rotor assembly and an impeller
coupled with
the rotor assembly, the rotor assembly comprising a concave bearing surface;
and providing a
drive unit proximal the impeller assembly, the drive unit comprising a drive
magnet and a
drive bearing between the drive magnet and the impeller assembly, the drive
bearing
comprising a convex bearing surface shaped to fit within the concave bearing
surface, the
convex bearing surface having a distal end disposed distal of a proximal end
of the rotor
assembly.
[0019] In some embodiments, providing the drive unit
comprises forming a
plurality of distally-projecting segments in the convex bearing surface, the
plurality of
distally-projecting segments spaced apart circumferentially to define at least
one channel
between adjacent segments. In some embodiments, the method comprises at least
partially
disposing the impeller in a pump housing. In some embodiments, the method
comprises
providing a support structure to be coupled to or formed with the pump
housing, the support
structure comprising struts configured to contact a blood vessel wall to
maintain spacing of
the pump housing from a blood vessel wall in which the pump housing is
disposed. In some
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embodiments, the method comprises providing a motor proximal the impeller, the
motor
configured to impart rotation to the impeller. In some embodiments, the method
comprises
connecting the motor to a power wire that extends proximally relative to the
motor.
[0020] In several embodiments, a blood flow assist system
is disclosed. In some
embodiments, the blood flow assist system includes or consists essentially of
an impeller
assembly comprising an impeller shaft, a first impeller disposed on the
impeller shaft, and a
second impeller disposed on the impeller shaft spaced apart proximally from
the first
impeller along the impeller shaft; and a drive unit configured to impart
rotation to the
impeller shaft, the drive unit having a distal end disposed distal a proximal
end of the second
impeller. In some embodiments, the first impeller is configured to pump blood
along a first
flow pathway along an exterior surface of the first impeller, a majority of
the blood flowing
along the first flow pathway being directed along a longitudinal axis of the
blood flow assist
system. In some embodiments, the system includes a fairing disposed about the
impeller
shaft between the first impeller and the second impeller, the first flow
pathway disposed
along an angled exterior surface of the fairing. In some embodiments, the
system includes a
second flow pathway through a lumen of the impeller shaft, the second impeller
configured
to direct blood from the second flow pathway radially outward relative to the
longitudinal
axis. In some embodiments, during operation of the blood flow assist system,
blood pumped
along the second flow pathway flows between a proximal end portion of the
impeller shaft
and the distal end of the drive unit.
[0021] In some embodiments, the drive unit comprises a
drive magnet and a drive
bearing between the drive magnet and the impeller assembly, the drive bearing
comprising a
convex bearing surface having a plurality of distally-projecting segments, the
plurality of
distally-projecting segments spaced apart circumferentially to define at least
one channel
between adjacent segments, the secondary flow pathway comprising the at least
one channel.
In some embodiments, the system includes a flange extending non-parallel from
a proximal
end portion of the impeller shaft, the second impeller disposed comprising a
plurality of
vanes on a generally proximally-facing surface of the flange. In some
embodiments, the
system includes an angled cavity extending inwardly and distally relative to
the generally
proximally-facing surface of the flange. In some embodiments, the drive unit
comprises a
convex member sized to fit within the angled cavity. In some embodiments, the
system
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includes a rotor magnet coupled to the impeller shaft, the rotor magnet
disposed adjacent a
distally-facing surface of the flange. In some embodiments, the system
includes a sleeve
bearing disposed about the impeller shaft at a location distal the first
impeller. In some
embodiments, in a cross-section taken perpendicular to an axis of rotation of
the first
impeller, a support surface of the sleeve bearing is disposed about only a
portion of a
perimeter of the impeller shaft at a selected axial location, such that, when
the impeller shaft
is rotated about the axis of rotation, an exterior surface of the impeller
shaft at the selected
axial location is cyclically exposed to blood during operation of the blood
flow assist system.
In some embodiments, the system includes a pump housing, the impeller assembly
disposed
at least partially within the pump housing. In some embodiments, the pump
housing includes
an outlet, the outlet disposed proximal the first impeller. In some
embodiments, the second
impeller is disposed proximal a distal end of the outlet. In some embodiments,
the system
includes a support structure coupled to or formed with the pump housing, the
support
structure comprising struts configured to contact a blood vessel wall to
maintain spacing of
the pump housing from a blood vessel wall in which the pump housing is
disposed. In some
embodiments, the first impeller comprises a plurality of outwardly-extending,
axially-aligned
blades. In some embodiments, a kit includes the blood flow assist system that
comprises a
motor assembly configured to impart rotation to the first impeller and the
second impeller
and a power wire electrically connected to the motor assembly. The kit can
include a console
configured to electrically connect to the power wire. In some embodiments, the
impeller
shaft, the second impeller, and the flange form an integrated rotor core, the
first impeller
attached to the impeller shaft. In some embodiments, the impeller shaft, the
first impeller,
the second impeller, and the flange form a unitary body.
[0022] In several embodiments, a blood pump is disclosed.
In some
embodiments, the blood pump includes or consists essentially of a primary
impeller, a flow
tube routed through the primary impeller, a rotatable piece comprising a
secondary impeller,
a conical opening, and the flow tube, and a drive unit sealed by a drive unit
cover, the drive
unit cover comprising a conical member that matches the contour of and fits
inside the
conical opening. In some embodiments, the drive unit comprises a magnet sealed
in the
drive unit cover. In some embodiments, the drive unit comprises a motor, the
magnet
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rotatable by the motor. In some embodiments, the secondary impeller comprises
a plurality
of vanes.
[0023] In several embodiments, a method of operating a
blood flow assist system
is disclosed. In some embodiments, the method includes or consists essentially
of
percutaneously delivering an impeller assembly to a treatment location in a
blood vessel of a
patient, the impeller assembly comprising an impeller shaft, a first impeller
disposed on the
impeller shaft, and a second impeller disposed on the impeller shaft spaced
apart proximally
from the first impeller along the impeller shaft; pumping blood along a first
flow pathway
and a second flow pathway, the first flow pathway disposed along an exterior
surface of the
first impeller, a majority of he blood flowing along the first flow pathway
being directed
along a longitudinal axis of the blood flow assist system, the second flow
pathway disposed
through a lumen of the impeller shaft, the second impeller directing blood
from the second
flow pathway radially outward relative to the longitudinal axis; and removing
the blood flow
assist system from the patient. In some embodiments, the method comprises
directing blood
radially outward between the second impeller and a drive unit, the drive unit
having a distal
end disposed distal of a proximal end of the second impeller. In some
embodiments, the
method comprises providing relative motion between the impeller assembly and a
sheath to
cause a plurality of struts to self-expand radially outwardly to engage a wall
of the blood
vessel. In some embodiments, the method comprises providing opposite relative
motion
between the impeller assembly and the sheath to cause the plurality of struts
to collapse
within the sheath. . In some embodiments, a sleeve bearing is disposed about
the impeller
shaft distal the first impeller, the method comprising cyclically exposing an
exterior surface
of the impeller shaft to blood at a selected axial location. In some
embodiments, the method
comprises supplying electrical current to a motor by way of a power wire, the
motor being
operably connected to the impeller assembly, the power wire extending outside
a body of the
patient.
[0024] In several embodiments, a method of manufacturing a
blood flow assist
system is disclosed. In some embodiments, the method includes or consists
essentially of
mounting a tint impeller on an impeller shaft, a flange disposed at a proximal
end of the
impeller shaft; and providing a second impeller spaced apart proximally from
the first
impeller along the impeller shaft, the second impeller disposed on a
proximally-facing
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surface of the flange. In some embodiments, the method comprises at least
partially
disposing the first impeller and the second impeller in a pump housing. In
some
embodiments, the method comprises providing a support structure to be coupled
to or formed
with the pump housing, the support structure comprising convex contact pads
configured to
contact a blood vessel wall to maintain spacing of the pump housing from a
blood vessel wall
in which the pump housing is disposed. In some embodiments, the method
comprises
comprising providing a motor proximal the second impeller, the motor
configured to impart
rotation to the impeller shaft. In some embodiments, the method comprises
connecting the
motor to a power wire that extends proximally relative to the motor, the motor
sized to be
inserted into a patient's vasculature and the power wire configured to extend
through the
vasculature to a location outside the patient's body.
[0025] In several embodiments, a blood flow assist system
is provided. In some
embodiments, the system comprises or consists essentially of an impeller (or
first impeller), a
lumen extending through the first impeller along a longitudinal axis of the
first impeller, a
primary flow pathway along an exterior surface of the first impeller, and a
secondary flow
pathway along the lumen. In some embodiments, the system includes an impeller
assembly
comprising an impeller shaft with the impeller disposed on the impeller shaft,
the impeller
shaft including the lumen extending from a distal end of the impeller shaft to
a proximal end
of the impeller shaft. In some embodiments, a drive unit configured to impart
rotation to the
impeller shaft and the impeller is provided, at least a portion of the drive
unit positioned
proximal the proximal end of the impeller shaft. In one embodiment, during
operation of the
blood flow assist system, blood is pumped proximally along the primary flow
pathway and
the secondary flow pathway. In some embodiments, the blood flow assist system
includes a
pump housing. In one embodiment, the primary flow pathway is disposed between
the
exterior surface of the first impeller and the pump housing is also provided.
For example, the
primary flow pathway can be disposed between (and extend from) a radially
outermost
surface of the first impeller to an internal wall of the pump housing. In one
embodiment,
during operation of the blood flow assist system, blood pumped along the
secondary flow
pathway flows between the proximal end of the impeller shaft and the drive
unit. In one
embodiment, the drive unit comprises a drive magnet and a drive bearing
between the drive
magnet and the impeller assembly, the drive bearing comprising a convex
bearing surface
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having a plurality of distally-projecting segments, the plurality of distally-
projecting
segments spaced apart circumferentially to define at least one channel between
adjacent
segments, the secondary flow pathway comprising the at least one channel. In
some
embodiments, a second impeller is disposed on the impeller shaft spaced apart
proximally
from the first impeller along the impeller shaft. The blood flow assist system
can include a
flange at a proximal end of the impeller shaft, the second impeller disposed
on a proximally-
facing surface of the flange. In some embodiments, the impeller shaft, the
second impeller,
and the flange form an integrated rotor core, the first impeller attached to
the impeller shaft.
In some embodiments, the impeller shaft, the first impeller, the second
impeller, and the
flange form a unitary body. In some embodiments, during operation of the blood
flow assist
system, blood pumped along the secondary flow pathway flows between a proximal
end of
the impeller shaft and the drive unit. In some embodiments, a kit can include
the blood flow
assist system that further includes a motor assembly configured to impart
rotation to the
impeller and a power wire electrically connected to the motor assembly. The
kit can include
a console configured to electrically connect to the power wire.
[0026] In several embodiments, a blood flow assist system
is disclosed. In some
embodiments, the blood flow assist system includes or consists essentially of
a pump
housing; an impeller assembly disposed in the pump housing, the impeller
assembly
comprising an impeller shaft and an impeller on the impeller shaft, the
impeller shaft
configured to rotate about an axis of rotation; and a sleeve bearing disposed
about the
impeller shaft distal the impeller. In some embodiments, the sleeve bearing
has an inner
support structure supporting the impeller shaft, an outer support structure
coupled to or
formed with the pump housing, and a connecting structure extending radially
between the
inner support structure and the outer support structure. In some embodiments,
the inner
support structure comprises a distal boundary, the distal boundary angled
relative to the axis
of rotation such that, in a cross-section taken perpendicular to the axis of
rotation, only a
portion of the distal boundary is disposed about the impeller shaft at a
selected axial location
along the axis of rotation, such that, when the impeller shaft is rotated
about the axis of
rotation, an exterior surface of the impeller shaft at the selected axial
location is cyclically
exposed to blood during operation of the blood flow assist system. In some
embodiments, in
a cross-section taken perpendicular to the axis of rotation, a support surface
of the sleeve
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bearing is disposed about only a portion of a perimeter of the impeller shaft
at a selected
axial location along the axis of rotation, such that, when the impeller shaft
is rotated about
the axis of rotation, an exterior surface of the impeller shaft at the
selected axial location is
cyclically exposed to blood during operation of the blood flow assist system.
In some
embodiments, at all axial locations along the axis of rotation along a length
of the sleeve
bearing, the support surface of the sleeve bearing is disposed only partially
about the
perimeter of the impeller shaft. In some embodiments, at an axial location
along the axis of
rotation, a support surface of the sleeve bearing is disposed only partially
about a perimeter
of the impeller shaft. In some embodiments, the system includes a drive unit
configured to
impart rotation to the impeller shaft, wherein the drive unit comprises a
drive magnet and a
drive bearing between the drive magnet and the impeller assembly, the drive
bearing
comprising a convex bearing surface and a plurality of distally-projecting
segments
extending from the convex bearing surface, the plurality of distally-
projecting segments
spaced apart circumferentially to define at least one channel between adjacent
segments.
[0027] In some embodiments, the support surface comprises a
crenulated surface
as shown in a side view of the sleeve bearing. In some embodiments, the
support surface is
disposed completely about the perimeter of the impeller shaft at a second
axial location along
the axis of rotation. In some embodiments, the system includes a pump housing,
the impeller
assembly disposed in the pump housing. In some embodiments, the system
includes a
support structure coupled with the pump housing, the support structure
comprising struts
configured to contact a blood vessel wall to maintain spacing of the pump
housing from a
blood vessel wall in which the pump housing is disposed. In some embodiments,
the
impeller is configured to pump blood along a first flow pathway along an
exterior surface of
the impeller, a majority of the blood flowing along the first flow pathway
being directed
along the axis of rotation. In some embodiments, the system includes a second
impeller
disposed on the impeller shaft spaced apart proximally from the impeller along
the impeller
shaft, the second impeller configured to direct blood radially outward
relative to the axis of
rotation from a second flow pathway in a lumen of the impeller shaft. In some
embodiments,
the system includes a flange extending non-parallel from a proximal end
portion of the
impeller shaft, the second impeller disposed on a generally proximally-facing
surface of the
flange. In some embodiments, a kit includes the blood flow assist system that
comprises a
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motor assembly configured to impart rotation to the impeller and a power wire
electrically
connected to the motor assembly. The kit can include a console configured to
electrically
connect to the power wire.
[0028] In several embodiments, a blood pump is disclosed.
In some
embodiments, the blood pump includes or consists essentially of a pump rotor
comprising a
primary impeller and a rotating member including a flow tube that rotates the
primary
impeller about an axis of rotation; and a sleeve bearing that fits around the
pump rotor, the
sleeve bearing comprising a bearing interface edge non-perpendicular to the
axis of rotation.
In some embodiments, the bearing interface edge comprises a non-circular
sleeve edge that
ensures that there are no points on the rotating member that remain aligned
with the sleeve
edge throughout rotation of the rotating member. In some embodiments, the
sleeve bearing
exposes at least one point on the rotating member throughout an entire height
of the sleeve
bearing so that a surface of the rotating member is only covered by the sleeve
bearing for a
portion of rotation. In some embodiments, the bearing interface edge comprises
an ellipse.
In some embodiments, the bearing interface edge varies in a sinusoidal manner.
[0029] In several embodiments, a method of operating a
blood flow assist system
is disclosed. In some embodiments, the method includes or consists essentially
of
percutaneously delivering an impeller assembly to a treatment location in a
blood vessel of a
patient, the impeller assembly disposed in the pump housing, the impeller
assembly
comprising an impeller shaft and an impeller on the impeller shaft, the
impeller shaft
configured to rotate about an axis of rotation, a sleeve bearing disposed
about the impeller
shaft; pumping blood through the blood flow assist system such that an
exterior surface of
the impeller shaft is cyclically exposed to blood at a selected axial
location; and removing the
impeller assembly from the patient. In some embodiments, at the selected axial
location
along the axis of rotation, a support surface of the sleeve bearing is
disposed only partially
about a perimeter of the impeller shaft. In some embodiments, the method
includes directing
blood longitudinally along a length of the impeller assembly and radially
outwardly between
a drive unit and a second impeller disposed proximal the impeller, the drive
unit having a
distal end disposed distal of a proximal end of the second impeller. In some
embodiments,
the method includes retracting a sheath to cause a plurality of struts to self-
expand radially
outwardly to engage a wall of the blood vessel.
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[00301 In several embodiments, a method of manufacturing a
blood flow assist
system is disclosed. In some embodiments, the method includes or consists
essentially of
disposing an impeller assembly disposed in a pump housing, the impeller
assembly
comprising an impeller shaft and an impeller on the impeller shaft, the
impeller shaft
configured to rotate about an axis of rotation; and disposing a sleeve bearing
about the
impeller shaft, wherein, at an axial location along the axis of rotation, a
support surface of the
sleeve bearing is disposed only partially about a perimeter of the impeller
shaft. In some
embodiments, the method includes providing a drive unit proximal the impeller
assembly, the
drive unit comprising a drive magnet and a drive bearing between the drive
magnet and the
impeller assembly, the drive bearing comprising a convex bearing surface
shaped to fit
within the concave bearing surface. In some embodiments, providing the drive
unit
comprises forming a plurality of distally-projecting segments in the convex
bearing surface,
the plurality of distally-projecting segments spaced apart circumferentially
to define at least
one channel between adjacent segments. In some embodiments, the method
includes
providing a support structure to be coupled to or formed with the pump
housing, the support
structure comprising struts configured to contact a blood vessel wall to
maintain spacing of
the pump housing from a blood vessel wall in which the pump housing is
disposed. In some
embodiments, the method includes providing a motor proximal the impeller, the
motor
configured to impart rotation to the impeller. In some embodiments, the method
includes
connecting the motor to a power wire that extends proximally relative to the
motor.
[0031] In several embodiments, a blood flow assist system
is disclosed. The
system can include or consist essentially of an impeller assembly comprising
an impeller
shaft, an impeller on the impeller shaft, a primary flow pathway disposed
along an exterior
surface of the impeller, a rotor assembly at a proximal portion of the
impeller shaft, the rotor
assembly comprising a concave bearing surface, a flange disposed about the
concave bearing
surface, a rotor magnet supported by the impeller shaft, and a second impeller
disposed on a
proximally-facing surface of the flange, wherein a secondary flow pathway is
disposed along
a lumen of the impeller shaft, and wherein, during operation of the blood flow
assist system,
blood is pumped proximally along the primary flow pathway and the secondary
flow
pathway; a sleeve bearing distal the impeller, the sleeve bearing disposed
about the impeller
shaft such that, during rotation of the impeller shaft, an exterior surface of
the impeller shaft
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at a selected axial location is cyclically exposed to blood during operation
of the blood flow
assist system; and a drive unit having a distal end disposed distal a proximal
end of the
second impeller, the drive unit comprising a drive magnet and a drive bearing
between the
drive magnet and the impeller assembly, the drive bearing comprising a convex
hearing
surface shaped to fit within the concave bearing surface and a plurality of
distally-projecting
segments, the plurality of distally-projecting segments spaced apart
circumferentially to
define at least one channel between adjacent segments, wherein the drive unit
is configured
to cause the drive magnet to impart rotation to the rotor magnet and the
impeller shaft. In
some embodiments, a kit includes the blood flow assist system that comprises a
motor
assembly configured to impart rotation to the impeller and a power wire
electrically
connected to the motor assembly. The kit can include a console configured to
electrically
connect to the power wire. In some embodiments, the blood flow assist system
comprises a
percutaneous pump configured for percutaneous insertion to a treatment
location within a
body of a patient.
[0032] In several embodiments, a blood flow assist system
is disclosed. In some
embodiments, the blood flow assist system includes or consists essentially of
a pump
configured for percutaneous insertion to a treatment location of a patient; an
elongate body
extending proximally from the pump; and a retrieval feature between a proximal
curved
portion of the pump and the elongate body, the retrieval feature comprising an
enlarged
diameter section and a neck between the enlarged diameter section and the
proximal curved
portion of the pump. In some embodiments, the enlarged diameter section
comprises a first
curved portion having a first radius of curvature and a second curved portion
having a second
radius of curvature different from the first radius of curvature. In some
embodiments, a first
plane extending parallel to a longitudinal axis of the blood flow assist
system and intersecting
the first curved portion defines a first angle between the proximal curved
portion and the first
curved portion, and a second plane extending parallel to the longitudinal axis
and intersecting
the second curved portion defines a second angle between the proximal curved
portion and
the second curved portion, the second angle different from the first angle. In
some
embodiments, the enlarged diameter section comprises a plurality of lobes
extending radially
outward. In some embodiments, the pump comprises a pump head and a motor
housing
coupled with the pump head, a proximal end portion of the motor housing
comprising the
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proximal curved portion. In some embodiments, the pump head comprises a pump
housing
and an impeller in the pump housing, and wherein the motor housing includes a
motor
operably coupled with the impeller. In some embodiments, the neck comprises a
first depth
at a first circumferential position of the retrieval feature and a second
depth less than the first
depth at a second circumferential position of the retrieval feature spaced
apart from the first
circumferential position.
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] These and other features, aspects and advantages are
described below with
reference to the drawings, which are intended for illustrative purposes and
should in no way
be interpreted as limiting the scope of the embodiments. Furthermore, various
features of
different disclosed embodiments can be combined to form additional
embodiments, which
are part of this disclosure. In the drawings, like reference characters denote
corresponding
features consistently throughout similar embodiments. The following is a brief
description of
each of the drawings.
[0034] FIG. 1A is a schematic perspective, partially-
exploded view of a blood
flow assist system, according to various embodiments.
[0035] FIG. 1B is a schematic perspective view of a pump at
a distal portion of
the blood flow assist system of FIG. 1A.
[0036] FIG. 1C is a schematic perspective, partially-
exploded view of the pump
of FIG. 1B.
[0037] FIG. 1D is a schematic side view of the pump
disposed in a collapsed
configuration in a delivery sheath.
[0038] FIG. lE is a schematic perspective view of a
retrieval feature used to
remove the pump, according to some embodiments.
[0039] FIG. 2A is a schematic perspective view of a
modified sleeve bearing
disposed about an impeller shaft distal an impeller of an impeller assembly.
[0040] FIG. 2B is a schematic front plan view of the sleeve
bearing of FIG. 2A.
[0041] FIG. 2C is a schematic side perspective view of the
sleeve bearing of FIG.
2B.
[0042] FIG. 2D is a schematic front plan view of the sleeve
bearing and impeller
assembly of FIG. 2A.
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[0043] FIG. 2E is a schematic side sectional view of the
impeller assembly and
sleeve bearing of FIG. 2D.
[0044] FIG. 2F is a schematic side sectional view of a non-
overlapping sleeve
assembly, according to another embodiment.
[0045] FIG. 2G is a schematic perspective view of a sleeve
bearing having a
crenulated pattern.
[0046] FIG. 2H is a schematic plan view of a sinusoidal
pattern of the sleeve
bearing of FIG. 2G.
[0047] FIG. 3A is a schematic perspective view of a drive
bearing according to
various embodiments.
[0048] FIG. 3B is a front end view of the drive bearing of
FIG. 3A.
[0049] FIG. 3C is a side view of the drive bearing of FIG.
3A.
[0050] FIG. 3D is a schematic front end view of a drive
bearing according to
another embodiment.
[0051] FIG. 3E is a schematic front end view of a drive
bearing according to
another embodiment.
[0052] FIG. 4A is a schematic perspective view of an
integrated rotor core
comprising an impeller shaft with flow tube and a secondary impeller.
[0053] FIG. 4B is a schematic perspective view of a
proximal portion of the
integrated rotor core of FIG. 4A.
[0054] FIG. 4C is a sectional view taken along the
longitudinal axis of the rotor
core of FIG. 4B.
[0055] FIG. 4D is a schematic proximal end view of the
integrated rotor core of
FIG. 4C.
[0056] FIG. 5A is a schematic perspective, exploded view of
a segmented cone
bearing comprising a proximal portion of the integrated rotor core and the
drive bearing.
[0057] FIG. 5B is a distal end sectional view of the
secondary impeller and drive
bearing.
[0058] FIG. 6 is a schematic, perspective exploded view of
a blood flow assist
system according to various embodiments.
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[0059] FIG. 7 is a schematic side sectional view of a pump
according to various
embodiments.
[0060] FIG. 8A is a schematic side sectional view of a
motor housing according
to various embodiments.
[0061] FIG. 8B is a schematic perspective view of a motor
and a motor mount
support.
[0062] FIG. 8C is a schematic perspective view of a distal
end of a power wire
configured to supply power to the motor.
[0063] FIG. 8D is a schematic perspective view of a
proximal end portion of the
power wire.
[0064] FIGS. 9A and 9B are schematic side sectional views
of primary and
secondary flow pathways through a pump according to various embodiments.
DETAILED DESCRIPTION
[0065] Refer now to the drawings wherein depicted elements
are not necessarily
shown to scale and wherein like or similar elements arc designated by the same
reference
numeral through the several views. Referring to the drawings in general, it
will be
understood that the illustrations are for the purpose of describing particular
implementations
of the disclosure and are not intended to be limiting thereto. While most of
the terms used
herein will be recognizable to those of ordinary skill in the art, it should
be understood that
when not explicitly defined, terms should be interpreted as adopting a meaning
presently
accepted by those of ordinary skill in the art.
I. OVERVIEW OF BLOOD FLOW ASSIST SYSTEMS
[0066] Various embodiments disclosed herein relate to a
blood flow assist system
1 configured to provide circulatory support to a patient, as illustrated in
FIGS. 1A-1D. The
system 1 can be sized for intravascular delivery to a treatment location
within the circulatory
system of the patient, e.g., to a location within the descending aorta of the
patient. As shown
in FIG. 1A, the system 1 can have a proximal end 21 with a connector 23
configured to
connect to an external control system, e.g., a console (not shown). The
connector 23 can
provide electrical communication between the control system and a power wire
20 extending
distally along a longitudinal axis L from the connector 23 and the proximal
end 21. The
power wire 20 can comprise an elongate body that electrically and mechanically
connects to
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a pump 2 at or near a distal end 22 of the blood flow assist system 1, with
the distal end 22
spaced apart from the proximal end 21 along the longitudinal axis L.
[0067] The pump 2 can comprise a pump head 50 including a
pump housing 35
connected to a drive unit 9 that includes a motor housing 29. A retrieval
feature 48 can he
provided at a proximal end portion of the pump 2. In some embodiments, the
retrieval
feature can he coupled with the distal end of the power wire 20 between the
power wire 20
and the motor housing 29. After a procedure, the clinician can remove the pump
2 from the
patient by engaging a tool (e.g., a snare, clamp, hook, etc.) with the
retrieval feature 48 to
pull the pump 2 from the patient. For example, the retrieval feature 48 can
comprise a neck
49 (e.g., a reduced diameter section) at a proximal curved portion 51c of the
motor housing
29 and an enlarged diameter section disposed proximal the neck 49. The
enlarged diameter
section can comprise a first curved portion 51a and a second curved portion 5
lb, as shown in
FIG. 1E. The first and second curved portions 51a, 51b can comprise convex
surfaces, e.g.,
convex ball portions. The first and second curved portions 51a, 5 lb can have
different radii
of curvature. For example, as shown in FIG. 1E, the first curved portion 51a
can have a
larger radius of curvature than the second curved portion 51b. The first
curved portion 51a
can be disposed on opposing sides of the retrieval feature 48 in some
embodiments. The
second curved portion 51b can be disposed around the first curved portion 51a
and can have
a radially-outward facing surface and a proximally-facing convex surface
coupled to the
distal end of the power wire 20. The neck 49 can have a first depth at a first
circumferential
position of the retrieval feature 48 and a second depth less than the first
depth at a second
circumferential position of the retrieval feature 48 spaced apart from the
first circumferential
position.
[0068] Beneficially, as shown in FIG. 1E, one or more first
planes P1 extending
parallel to the longitudinal axis L and intersecting the first curved portion
51a can have a first
angle or taper between the proximal curved portion 51c of the motor housing 29
and the first
curved portion 51a. One or more second planes P2 extending parallel to the
longitudinal axis
L and intersecting the second curved portion 5 lb can have a second angle or
taper (which is
different from the first angle or taper) between the proximal curved portion
51c of the motor
housing 29 and the second curved portion 51b. The first angle or taper can
provide a
gradual, continuous (generally monotonically decreasing) geometric transition
between the
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proximal curved portion 51c of the motor housing 29 and the power wire 20,
which can
provide for smooth blood flow and reduce the risk of thrombosis. The second
curved portion
lb can serve as a lobe that extends radially outward, e.g., radially farther
out than the first
curved portion 51a. The second curved portion 51h can he used to engage with a
retrieval
device or snare to remove the pump 2 from the anatomy. Some cross sections
through the
longitudinal axis of the retrieval feature 48 can contain a substantial neck
(e.g., a local
minimum in the radius of curvature measured along its central axis) while
other cross
sections through the longitudinal axis of the retrieval feature 48 can contain
an insubstantial
local minimum or no local minimum. In the illustrated embodiment, there are
two first
curved portions 51a that can serve as a dual lobe retrieval feature. In other
embodiments,
more or fewer lobes can be provided to enable pump retrieval while ensuring
smooth flow
transitions between the motor housing 29 and power wire 20.
[0069] As shown in FIGS. 1B-1C and 1E, the neck 49 can be
disposed between
the curved portions 51a, 51b and the proximally-facing convex surface 51c of
the motor
housing 29. In the illustrated embodiment, the retrieval feature 48 can be
coupled to or
integrally formed with the motor housing 29. In other arrangements, the
retrieval feature 48
can be disposed at other locations of the pump 2. As shown, the retrieval
feature 48 can be
symmetrical and continuously disposed about the longitudinal axis L. In other
anangements,
the retrieval feature 48 can comprise a plurality of discrete surfaces spaced
apart
circumferentially and/or longitudinally.
[0070] In the illustrated embodiments, the motor housing 29
(and motor) can be
part of the pump 2 and disposed inside the vasculature of the patient in use.
In other
embodiments, however, the motor housing 29 (and motor) can be disposed outside
the
patient and a drive cable can connect to the impeller 6.
[0071] As shown in FIGS. 1A-1C, the drive unit 9 can be
configured to impart
rotation to an impeller assembly 4 disposed in the pump housing 35 of the pump
head 50. As
explained herein, the drive unit 9 can include a drive magnet 17 and a motor
30 (see FIGS. 6-
8A) disposed in the motor housing 29 capped by a distal drive unit cover 11.
The drive unit
cover 11 can be formed with or coupled to a drive bearing 18. The drive magnet
17 can
magnetically couple with a corresponding driven or rotor magnet 12 (see FIG.
7) of the
impeller assembly 4 that is disposed within the shroud 16 proximal the
impeller 6. The
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power wire 20 can extend from the treatment location to outside the body of
the patient, and
can provide electrical power (e.g., electrical current) and/or control to the
motor 30.
Accordingly, no spinning drive shaft extends outside the body of the patient
in some
embodiments. As explained herein, the power wire 20 can energize the motor 12,
which can
cause the drive magnet 17 to rotate about the longitudinal axis L, which can
serve as or be
aligned with or correspond to an axis of rotation. Rotation of the drive
magnet 17 can impart
rotation of the rotor magnet 12 and a primary or first impeller 6 of the
impeller assembly 4
about the longitudinal axis L. For example, as explained herein, the rotor
magnet 12 can
cause an impeller shaft 5 (which can serve as a flow tube) to rotate which, in
turn, can cause
the first impeller 6 to rotate to pump blood. In other embodiments, the drive
unit 9 can
comprise a stator or other stationary magnetic device. The stator or other
magnetic device
can be energized, e.g., with alternating current, to impart rotation to the
rotor magnet 12. In
the illustrated embodiments, the impeller 6 can have one or a plurality of
blades 40 extending
radially outward along a radial axis R that is radially transverse to the
longitudinal axis L.
For example, the first impeller 6 can have a plurality of (e.g., two) axially-
aligned blades 40
that extend radially outwardly from a common hub and that have a common length
along the
longitudinal axis L. The curvature and/or overall profile can be selected so
as to improve
flow rate and reduce shear stresses. Skilled artisans would appreciate that
other designs for
the first impeller 5 may be suitable.
[0072] As shown in FIGS. 1A-1C, the impeller assembly 4 can
be disposed in a
shroud 16. The impeller shaft 5 can be supported at a distal end by a sleeve
bearing 15
connected to a distal portion of the shroud 16. A support structure such as a
localization
system can comprise a base portion 36 coupled with the sleeve bearing 15
and/or the shroud
16. In some embodiments, the base portion 36, the sleeve bearing 15, and/or
the shroud 16
can be welded together. The base portion 36 of the support structure or
localization system,
the sleeve bearing 15, and the shroud 16 can cooperate to at least partially
define the pump
housing 35, as shown in FIGS. lA and 1C. The localization system can comprise
a plurality
of self-expanding struts 19 having convex contact pads 24 configured to
contact a blood
vessel wall to maintain spacing of the pump housing 35 from the blood vessel
wall in which
the pump housing 35 is disposed. In FIGS. 1A-1C, the struts 19 of the
localization system
are illustrated in an expanded, deployed configuration, in which the contact
pads 24 extend
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radially outward to a position in which the contact pads 24 would contact a
blood vessel wall
within which the pump 2 is disposed to at least partially control position
and/or orientation
of, e.g., to anchor, the pump 2 during operation of the system 1.
[0073] A first fluid port 27 can be provided distal the
impeller assembly 4 at a
distal end of the pump housing 35. The shroud 16 can comprise a proximal ring
26 coupled
with the motor housing 29 and a plurality of second fluid ports 25 formed in a
proximal
portion of the shroud 16 adjacent (e.g., immediately distal) the proximal ring
26. As shown
in FIG. 1C, the second fluid ports 25 can comprise openings formed between
axially-
extending members 60 that extend along the longitudinal axis L between the
proximal ring 26
and a cylindrical section 59 of the shroud 16. In some embodiments, the
axially-extending
members 60 (also referred to as pillars) can be shaped to serve as vanes that
can shape or
direct the flow of blood through the second fluid ports 25. For example, in
various
embodiments, the axially-extending members 60 can be angled or curved to match
the profile
of the impeller blades 40. In other embodiments, the axially-extending members
60 may not
be angled to match the blades 40. In some embodiments, the first fluid port 27
can comprise
an inlet port into which blood flows. In such embodiments, the impeller
assembly 4 can
draw blood into the first fluid port 27 and can expel the blood out of the
pump 2 through the
second fluid ports 25, which can serve as outlet ports. In other embodiments,
however, the
direction of blood flow may be reversed, in which case the second fluid ports
25 may serve
as fluid inlets and the first fluid port 27 may serve as a fluid outlet.
[0074] Beneficially, the blood flow assist system 1 can be
delivered
percutaneously to a treatment location in the patient. FIG. 1D shows the pump
2 disposed
within an elongate sheath 28. As shown, the struts 19 are held in a collapsed
configuration
by the inner wall of the sheath 28. In the collapsed configuration, the struts
19 can be
compressed to a diameter or major lateral dimension at one or more locations
that is
approximately the same (or slightly smaller than) the diameter of the shroud
16. The patient
can be prepared for the procedure in a catheterization lab in a standard
fashion, and the
femoral artery can be exposed. The sheath 28 (or a dilator structure within
the sheath 28) can
be passed over a guidewire and placed into the treatment location, for
example, in the
descending aorta. After the sheath 28 is placed, the pump 2 can be advanced
into the sheath
28, with the pump 2 disposed in the mid-thoracic aorta, approximately 4 cm
below the take-
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off of the left subclavian artery. In other embodiments, the pump 2 and sheath
28 can be
advanced together to the treatment location. Positioning the pump 2 at this
location can
beneficially enable sufficient cardiac support as well as increased perfusion
of other organs
such as the kidneys. Once at the treatment location, relative motion can be
provided between
the sheath 28 and the pump head (e.g., the sheath 28 can be retracted relative
to the pump 2,
or the pump 2 can be advanced out of the sheath 28). The struts 19 of the
localization system
can self-expand radially outwardly along the radial axis R due to stored
strain energy into the
deployed and expanded configuration shown in FIGS. 1A-1C. The convex contact
pads 24
can engage the blood vessel wall to stabilize (e.g., anchor) the pump 2 in the
patient's
vascular system. Once anchored at the treatment location, the clinician can
engage the
control system to activate the motor 30 to rotate the impeller assembly 4 to
pump blood.
[0075] Thus, in some embodiments, the pump 2 can be
inserted into the femoral
artery and advanced to the desired treatment location in the descending aorta.
In such
arrangements, the pump 2 can be positioned such that the distal end 22 is
upstream of the
impeller 6, e.g., such that the distally-located first fluid port 27 is
upstream of the second
fluid port(s) 25. In embodiments that access the treatment location via the
femoral artery, the
first fluid port 27 can serve as the inlet to the pump 2, and the second ports
25 can serve as
the outlet(s) of the pump 2. In other embodiments, however, the pump 2 can be
inserted
percutaneously through the left subclavian artery and advanced to the desired
treatment
location in the descending aorta. In such arrangements, the pump 2 can be
positioned such
that the distal end 22 of the system 1 is downstream of the impeller 6, e.g.,
such that the
distally-located first fluid port 27 is downstream of the second fluid port(s)
25. In
embodiments that access the treatment location through the left subclavian
artery, the second
fluid port(s) 25 can serve as the inlet(s) to the pump 2, and the first port
27 can serve as the
outlet of the pump 2.
[0076] When the treatment procedure is complete, the pump 2
can be removed
from the patient. Relative motion opposite to that used for deploying the pump
2 can be
provided between the sheath 28 and the pump 2 (e.g., between the sheath 28 and
the impeller
assembly 4 and pump housing 35) to collapse the struts 19 into the sheath 28
in the collapsed
configuration. In some embodiments, the pump 2 can be withdrawn from the
sheath 28 with
the sheath 28 in the patient's body, and the sheath 28 can subsequently
removed. In other
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embodiments, the sheath 28 and the pump 2 can be removed together from the
patient's
body.
II. MODIFIED SLEEVE BEARINGS
[0077]
As explained above, in some embodiments the sleeve bearing 15 can
support a distal end portion 5A of the impeller shaft 5, which can support the
first impeller 6
and can also serve as a flow tube. Designs may be generally described from a
perspective in
which the central axis of rotation of the impeller assembly 4 is oriented
along the
longitudinal axis L of the system 1, e.g., vertically for purposes of
discussion in some
instances. As used herein, proximal and distal ends (or end portions) of a
component may be
axially spaced apart along the longitudinal axis L of the system 1. Thus, the
sleeve bearing
15 may be described interchangeably in tel
__________________________________________ las of an associated length or
height, which extend
along the longitudinal axis L. Generally, a rotating member (a shaft or tube
such as the
impeller shaft 5 shown and described herein) rotating inside a tubular sleeve
or bearing has a
bearing surface that is cylindrically shaped as an open right circular
cylinder. This standard
bearing design has circular proximal and distal edges (e.g., upper and lower
interface edges)
that are perpendicular to the longitudinal axis L of the rotating member or
axis of rotation,
and a cylindrical bearing surface between the edges that remains covered and
unexposed by
the bearing body. Further, there is a circular set of points where the
rotating member (e.g.,
the shaft 5) and bearing interface with one another, which may be referred to
herein as a
bearing interface or interface edge. In other words, any point on this circle
on the rotating
member is always perpendicularly aligned with the edge of the sleeve. This
condition has
been shown to encourage thrombus formation at the sleeve edge(s). This
thrombus may grow
to form a complete ring around the sleeve edge, thereby impeding proper
operation.
[0078]
The designs of the modified sleeve bearing 15 described herein have a
novel design to reduce or prevent thrombus formation during operation. Turning
to FIGS.
2A-2E, one embodiment of such a sleeve bearing 15 is illustrated. The sleeve
bearing 15 can
comprise an inner support structure including an inner sleeve 37 that supports
the distal
portion 5A of the impeller shaft 5. The inner sleeve 37 can be mechanically
coupled to the
first impeller 6 in some embodiments, e.g., by way of a thrust ring bearing 14
(see FIG. 6).
The thrust bearing 14 can be laser welded to the inner sleeve 37 in one
embodiment. In other
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embodiments, there may be no thrust bearing 14 between the first impeller 6
and the inner
sleeve 37. The sleeve bearing 15 can further include an outer support
structure comprising
an outer annular or cylindrical member, sometimes referred to herein as an
outer sleeve or
outer bearing carrier 38 connected to the shroud 16. The outer sleeve or
bearing carrier 38
can comprise a small radially outer portion of the sleeve bearing 15. A
connecting structure
39 can extend radially between the inner sleeve 37 and the outer bearing
carrier 38 to connect
the inner sleeve 37 and the outer bearing carrier 38. In variations the
connecting structure 39
can be coupled directly to the shroud 16. The outer bearing carrier 38 can be
eliminated in
one embodiment. The outer bearing carrier 38 can be integrated into or be part
of the shroud
16, such that the structure is a monolithic construction and not the assembly
of multiple parts.
In other variations the connecting structure 39 can be indirectly coupled to
the shroud 16
through a structure other than the annular member or bearing carrier 38.
[0079] As explained herein, the pump 2 can have a primary
or first flow pathway
3A. Blood can flow along the first flow pathway 3A between the outer bearing
carrier 38
and the inner sleeve 37 and along an exterior surface of the first impeller 6.
A majority of the
blood flow (e.g., a majority of the momentum of the total blood flow) through
the pump 2
can pass along the primary or first flow pathway 3A. The first flow pathway 3A
can extend
radially between the rotating first impeller 6 and the stationary pump housing
35.
Accordingly, blood can flow over the rotating outermost surface of the first
impeller 6
between the first impeller 6 and the stationary inner wall of the pump housing
35. The pump
2 can also have a secondary or second flow pathway 3B along a lumen of the
impeller shaft
5, which as explained herein can serve as a flow tube. A minority of the total
blood flow can
flow along the secondary flow pathway 3B. For example, in some embodiments,
the volume
flow of blood along the secondary flow pathway 3B can be in a range of 0.5% to
10% of the
volume flow of blood along the primary flow pathway 3A, in a range of 1% to 5%
of the
volume flow of blood along the primary flow pathway 3A, or in a range of 2% to
3% of the
volume flow of blood along the primary flow pathway 3A.
[0080] As shown in FIGS. 2A, 2C, and 2E, the inner sleeve
37 can have a bearing
interface surface 41 extending between a proximal edge 37B (or "lower edge" if
viewed
vertically) and a distal edge 37A (or "upper edge" if viewed vertically)
spaced apart from the
proximal edge 37B along the longitudinal axis L. The sleeve bearing 15 can be
shaped so
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that one or more bearing interface surfaces 41 and / or interface edges (37A,
37B) of the
inner sleeve 37 are not perpendicular to the axis of rotation or longitudinal
axis L of the
sleeve bearing 15. In one embodiment, the bearing interface surface 41 may
comprises edges
37A, 37B that form ellipse(s) tilted or tapered with respect to the
longitudinal axis L of the
sleeve bearing 15 (FIGS. 2A-2E). In another embodiment, as explained below,
the bearing
surface(s) 41 may vary in a sinusoidal way to create crenulated edge(s) (see
FIG. 2F). These
or other shapes that result in non-circular sleeve edges 37A, 37B ensure that
there are no
points on the rotating member or impeller shaft 5 that remain aligned with the
sleeve edges
37A, 37B throughout the rotation of the rotating member (e.g., shaft 5),
thereby minimizing
the potential for thrombus formation. Whereas conventional designs leave an
entire right
circular cylinder section covered, the modified sleeve bearings 15 expose at
least one point
on the rotating member or shaft 5 throughout the entire length (or height if
the sleeve bearing
is viewed as being vertically oriented) of the sleeve bearing 15 so that the
rotating member
bearing interface surface 41 is only covered by the sleeve bearing for a
portion of rotation.
As such, the interfacing bearing surface(s) 41 may have better exchange of the
lubricating
layer of blood than conventional designs.
[0081] Thus, in some embodiments, the distal edge 37A can
comprise a distal
boundary of the inner sleeve 37. The distal boundary (e.g., the distal edge
37A) can be
angled relative to the axis of rotation (which is aligned with the
longitudinal axis L) such
that, in a cross-section taken perpendicular to the axis of rotation L, only a
portion of the
distal boundary (e.g., distal edge 37A) is disposed about the impeller shaft 5
at a selected
axial location along the axis of rotation. In some embodiments, only a portion
of a proximal
boundary can be disposed about the impeller shaft 5 at a selected axial
location along the axis
of rotation. For example, as shown in FIG. 2E, the bearing interface surface
41 can have
exposed axial regions 42A, 42B comprising axial location(s) at which an
exterior surface 5'
(see FIG. 2A) of the impeller shaft 5 is cyclically exposed to blood that
flows along the first
flow pathway 3A. In the exposed axial regions 42A, 42B, the bearing interface
surface 41 is
disposed about only a portion of a perimeter (e.g., circumference) of the
impeller shaft 5.
Accordingly, when the impeller shaft 5 is rotated about the axis of rotation
(aligned with the
longitudinal axis L), an exterior surface of the impeller shaft 5 at a
selected axial location
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within the exposed axial regions 42A, 42B is cyclically exposed to blood flow
in the first
pathway 3A during operation of the blood flow assist system 1.
[0082] In some embodiments, such as that shown in FIGS. 2A-
2E, the inner
sleeve 37 may he partially axially overlapping along the longitudinal axis L.
As shown in
FIG. 2E, for example, at an example overlapping cross-sectional plane 43, the
bearing
surface 41 of the inner sleeve 37 may be disposed completely around the
exterior surface of
the impeller shaft 5 such that the exterior surface 5' of the shaft 5 at that
overlapping cross-
sectional plane 43 is not exposed to blood flow in the first pathway 3A. For
example, in
some embodiments, the sleeve bearing 15 can have a length along the
longitudinal axis L.
The inner sleeve 37 may be partially overlapping by an amount in a range of 1%
to 50% of
the length of the sleeve bearing 15, in a range of 5% to 50% of the length of
the sleeve
bearing 15, in a range of 10% to 50% of the length of the sleeve bearing 15,
in a range of
20% to 40% of the length of the sleeve bearing 15, or in a range of 25% to 35%
of the length
of the sleeve bearing 15 (e.g.. about 30% of the length of the sleeve bearing
15 in some
embodiments).
[0083] In other embodiments, such as that shown in FIG. 2F,
a sleeve bearing
15A can comprise an inner sleeve 37 which may be non-overlapping such that
there are no
points on the exterior smface 5' of the impeller shaft 5 that remain covered
by the bearing
interface surface 41 during rotation of the impeller shaft 37. In FIG. 2F, all
axial locations
along the length of the inner sleeve 37 comprise an exposed axial region 42,
such that the
bearing surface 41 of the inner sleeve 37 is disposed only partially about the
perimeter of the
impeller shaft 5 at all axial locations along the length of the inner sleeve
37. For example,
the edge(s) 37A, 37B can comprise non-circular edge(s) that ensures that there
are no points
on the rotating member or shaft 5 that remain aligned with the sleeve edge(s)
37A, 37B
throughout an entire rotation of the rotating member or shaft 5. The sleeve
bearing 15A can
therefore expose at least one point on the rotating member or shaft 5
throughout an entire
length (or height) of the sleeve bearing 15A so that the exterior surface 5'
of the shaft 5 is
only covered by the inner sleeve 37 for a portion of rotation.
[0084] Accordingly, in some embodiments the bearing edges
37A, 37B are
shaped so that maximum length (or height) of the lower or proximal edge 37B is
above
minimum length (or height) of the upper or distal edge 37A in one or more
locations around
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the circumference of the inner sleeve 37 (FIGS. 2E & 3F). In these
embodiments, there is at
least one point on the bearing interface surface 41 throughout the length (or
height) of the
bearing interface surface 41 that is exposed and that is not covered by the
inner sleeve 37 of
the sleeve bearing 15, 15A. In other words, the sleeve bearing 15, 15A never
covers 3600 of
the rotating member or shaft 5 throughout the entire length or height of the
bearing interface
region 41. This interrupted contact of the disclosed embodiments promotes
exchange of a
lubricating layer blood over the entire bearing interface 41 and does not
allow blood to
stagnate or become trapped.
[0085] In some embodiments, the tilt or taper of the sleeve
edges 37A, 37B with
respect to the longitudinal axis L (and the axis of rotation) may also
generate or enhance fluid
dynamic forces that contribute to proper bearing operation and reduce contact
and wear of
the bearing parts. As one non-limiting example, the fluid near the surface of
a particular spot
on the rotating member (e.g., shaft 5) may experience increases and decreases
in pressure as
it moves under and out from under the inner sleeve 37. These pressure changes
contribute to
lubricating layer foimation and dispersal.
[0086] The interface between the sleeve bearing 15, 15A and
the rotating member
(e.g., shaft 5) is lubricated by blood. Depending on geometry, materials used,
and operating
conditions, this lubrication may be hydrodynamic lubrication,
elastohydrodynamic
lubrication, boundary lubrication, or mixed lubrication. The varying exposure
of the rotating
member surface and/or varying edge profile of the sleeve bearing edges 37A,
37B may be
designed to help encourage a fluid wedge to improve lubrication. As a non-
limiting example,
viscous drag from a surface patch of the rotating member or shaft 5 may
increase fluid
pressure above that surface patch as it rotates under the sleeve edge(s) 37A,
37B. In some
embodiments, the cross-section of the inner bearing surface 41 of the sleeve
37 may
optionally be made non-circular to aid in wedge pressure generation, for
example by varying
the wall thickness of the inner sleeve 37. The sleeve edge profile of the
edges 37A, 37B may
be beveled or rounded to augment this pressure generation.
[0087] FIGS. 2G and 2H illustrate another example of a
sleeve bearing 15B that
has a non-overlapping design. The sleeve bearing 15B comprises a crenulated
bearing in
which the bearing interface surface 41 is disposed about the longitudinal axis
L in a
repeating, undulating or in some cases a sinusoidal pattern 44. The sinusoidal
pattern 44 can
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have alternately exposed gaps about the perimeter of the impeller shaft 5
during rotation such
that all axial locations along the length of the sleeve bearing 15B are
cyclically exposed to
blood flow during operation of the system 1. FIG. 2G shows the inner sleeve
37' can have an
undulating pattern that has a plurality of (e.g., two) distal peaks 61 and a
plurality of (e.g.,
two) proximal peaks 62. For example, as shown in FIG. 2G, the peaks 61, 62 can
be
generally flat with arcuate sections 64 extending between the peaks 61, 62. A
gap 63
between the arcuate sections 64 can provide for the cyclical exposure of the
shaft 5 to blood
flow. Thus, during rotation, the shaft 5 can transition from covered by the
arcuate sections
64 to being uncovered and exposed through the gaps 63. In other variations,
there can be
more than two peaks in the undulating pattern of the sleeve 37'. FIG. 2H shows
an inner
sleeve 37" with another crenulated structure with a sinusoidal patterns, e.g.,
with curved
peaks 61, 62. In some arrangements, the use of curved peaks 61, 61 (as opposed
to sharp or
flat peaks) may beneficially allow for smoother flow profiles.
[0088] The rotating member 5 and the sleeve bearings 15,
15A, 15B may each be
made of any suitable blood compatible material. As a non-limiting example, the
rotating
member (e.g., the impeller shaft 5) may comprise a flow tube made out a
biocompatible
polymer, e.g., of PEEK or polyethylene and/or the sleeve bearing 15, 15A, 15B
may he made
out of a metal, e.g., titanium or stainless steel. Making the rotating member
or shaft 5 as a
plastic tube may increase the range over which elastohydrodynamic lubrication
is present.
For example, the use of materials that enable elastic deformation of the
materials during
operation can provide an improved pressure profile.
III. MODIFIED CONE BEARINGS
[0089] As shown in FIGS. 1A, 1C and 6, the drive unit 9 can
comprise a drive
magnet 17 and a drive bearing 18 between the drive magnet 17 and the impeller
assembly 4.
The drive bearing 18 can provide a magnetic coupling and a fluid bearing
interface between
the drive magnet 17 and a rotor assembly 46 that comprises the driven or rotor
magnet 12
and an integrated rotor core 8 that includes the impeller shaft 5 and a
secondary impeller 7, as
shown in FIG. 6. In various embodiments, the drive bearing 18 can comprise a
segmented
cone bearing. Cone bearings can comprise a convex (e.g., generally conical)
shaped member
45 seated inside a generally concave (e.g., conical) opening 32 or cavity of
the rotor
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assembly 46. The concave opening 32 can serve as a concave bearing surface
sized and
shaped to mate with the convex member 45. The concave opening 32 can comprise
an
angled concave cavity sized to receive the convex member 45. The drive unit 9
can comprise
a convex member sized to fit within the angled cavity of the concave opening
32.
[0090] The bearing interface region of this bearing design
can be formed by the
matching surfaces of the conical or convex member 45 and the conical or
concave opening
32 and the space between them. A cone bearing can provide both axial and
radial
confinement. The axial confinement from a single cone bearing can be in one
direction only.
Cone bearings with steep slopes provide relatively more radial confinement,
and cone
bearings with shallower slopes provide relatively more axial confinement. In
some
embodiments, the conical shaped member 45 can be modified to reduce hemolysis
and/or
clotting. In some embodiments, the conical member 45 can be truncated by a
cylinder coaxial
to the axis of the cone (or axis of rotation) to remove base portions of the
cone. In some
embodiments, the conical member 45 can be truncated by a plane perpendicular
to the axis of
the cone (creating a frustrum or a frustoconical surface). In other
embodiments, the conical
member 45 can be truncated by both a cylinder and a cone. In some embodiments,
the
surface of the conical opening 32 may be modified in a similar manner in
conjunction with
the conical member 45 or instead of the conical member 45. One or the other or
both of the
surfaces of the conical member 45 and conical opening 32 may also be modified
by holes,
gaps, channels, grooves, bumps, ridges, and/or projections. Each of the
surfaces of the
conical member 45 and conical opening 32 may also be formed as part of other
components
of the pump with any overall shape.
[0091] Given the general possibility of holes, grooves,
channels, or gaps in either
the conical member 45 and/or conical opening 32, either of their surfaces
comprise of a
plurality of separate bearing surfaces in the plane of the generally conical
shape defining the
member 45 or opening 32. In such a manner the opening 32 and/or the conical
member 45 of
the bearing pair may be formed by a plurality of separate surfaces or a
segmented surface.
The plurality of separate surfaces or the segmented surface that make up
either the conical
member 45 or conical opening 32 of the bearing pair may extend from the same
component
or part, or may extend from distinct components or parts. Grooves and gaps in
either the
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conical member 45 and/or conical opening 32 may be created by removing
material from a
single generally conical surface or by using a plurality of separate surfaces.
[0092] In some embodiments of a modified cone bearing, the
conical member 45
of the bearing pair can comprise a convex hearing surface having a segmented
frustoconical
shape formed from a plurality of distally-extending segments 33 (FIGS. 3A-3D).
The
distally-extending segments 33 can extend distally from the drive unit cover
11. The
segments 33 can be spaced apart circumferentially to define at least one
channel 34 between
adjacent segments 33. Three segments 33 are shown in FIGS 3A-3D, but any
suitable
number of segments 33 may be utilized. As shown, the segments 33 can be
separate
components arising from a common part with gaps or channels 34 between them,
but the
segments 33 may also be separated by shallow or deep grooves. The gaps,
grooves or
channels 34 may follow any path. In the illustrated embodiment, the channel(s)
34 extend
radially outward from a central recess or hollow 31 (also referred to herein
as a void) at a
location proximal a proximal end portion 5B of the impeller shaft 5. In some
embodiments,
the width and depth of any groove or channel 34 may vary along its path. In
some
embodiments, two or more channels 34 may join or separate. In certain
embodiments, two or
more channels 34 may join to form the central hollow area 31 coaxial with the
axis of the
conical surfaces and/or with the longitudinal axis of rotation L. In some
embodiments, the
conical opening 32 of the bearing pair can be a continuous (e.g., no gaps,
channels, or
grooves), generally conical surface. The relative angles of the cone bearings
(e.g., the
segments 33) and spacing between segments 33 can be selected to provide a
desired flow
profile through the channel(s) 34 described herein. For example, increased
spacing between
the segments 33 can provide increased flow through the channels 34. Together,
the
segmented conical member 45 of the drive bearing 18 with channels 34 between
the
segments 33 and the continuous conical opening 32 can serve as a "segmented
cone bearing".
[0093] The channels 34 between the segments 33 allow
interrupted contact
between bearing surfaces similar to the interrupted contact described above
for the modified
sleeve bearing 15, 15A, 15B discussed previously. This interrupted contact
provides, without
limitation, benefits for the segmented cone bearing analogous to those it
provides to the
modified sleeve bearing 15, 15A, 15B. For example, in embodiments in which the
conical
opening 32 is part of the rotating member (e.g., the impeller shaft 5), the
channels 34
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between the segments 33 can ensure that at least one point throughout the
length or height of
the conical opening 32 on the rotating member 5 is intermittently exposed by
the conical
opening 32 and not continuously covered by the bearing pair. This design
promotes exchange
of a lubricating layer blood over the entire bearing interface. The channels
34 also generate
pressure changes that contribute to lubricating layer formation and dispersal
as described
above for the sleeve bearing 15, 15A, 15B.
[0094] In some embodiments, additional features may promote
blood flow
through the central hollow 31 and channels 34 of the segmented cone bearing.
In some
embodiments blood may flow in through the channels 34 and exit via the central
hollow 31.
In other embodiments blood may flow into the central hollow 31 (e.g., from the
secondary
flow pathway 3B of the impeller shaft 5) and exit via the channels 34. This
net flow of blood
through the central hollow 31 and channels 34 may serve to ensure the volume
of blood in
the channels 34 and central hollow 31 is constantly flowing to provide a
source of fresh
blood for lubricating layer exchange, to carry away heat, and/or to reduce the
time that blood
is exposed to conditions within the bearing region that may increase the
potential for
hemolysis or thrombus formation. Accordingly, in various embodiments, a
concave bearing
surface (which can comprise or be defined by the concave opening 32) can
include a fluid
port to deliver blood proximally along the second flow pathway 3B. The convex
bearing
surface (which can comprise the convex member 45) can including a void (e.g.,
the central
hollow 31), which can be disposed on the longitudinal axis L. The one or more
channels 34
can extend radially outward from the void or central hollow 31. The void can
be in fluid
communication with the fluid port (e.g., an interface between the flow tube 5
and the conical
opening 32) so as to direct blood radially outward along at least one channel
34.
[0095] As shown in FIG. 5A, the segments 33 of the convex
member 45 can be
shaped to fit within the concave bearing surface comprising the concave
opening 32. In
some embodiments, as shown in FIGS. 4A-5B, a direct secondary flow pathway 3B
(for
example through the flow tube of the impeller shaft 5 shown in FIGS. 4B-4D and
5B) may
provide proximally-flowing blood into the central hollow 31. In some
embodiments a
secondary or second impeller 7 may be used to drive the secondary flow of
blood through the
bearing region, e.g., through the second flow pathway 3B, the central hollow
32, and radially
outwardly through the channel(s) 34. The primary impeller 6 of the pump and/or
the
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additional secondary impeller 7 may assist in drawing the blood proximally and
directing the
blood radially outwardly along the channel(s) 34. FIGS. 4A-4D show the
secondary impeller
7 that draws blood out through the channels 34 of the segmented cone bearing.
As explained
herein, the secondary impeller 7 and impeller shaft 5 can form an integrated
rotor core 8.
The secondary impeller 7 can have a plurality of vanes 10 as explained herein
to assist in
directing blood radially outward through the channel(s) 34 of the drive
bearing 18.
[0096] Keeping the segmented cone bearing elements or
segments 33 near the
central longitudinal axis L of the pump can have several advantages. For
example, in the
illustrated embodiment, the bearing elements 33 can be more directly exposed
to the blood
flow from the flow tube of the impeller shaft 5 along the second flow pathway
3B. Further,
the bearing elements 33 can have a smaller radius where the linear speed of
the rotating
member is lower. Placing the bearing elements or segments 33 near the axis L
of the pump
allows the vanes 10 of the secondary impeller 7 to be placed at a greater
radius where the
linear speed of the rotating member or shaft 5 is higher.
[0097] FIG. 3D shows an embodiment in which the channels 34
between the
segments 33 follow a curved path from the central hollow 31. The channels 34
en be
configured to increase flow and reduce shear forces on the blood. In some
embodiments, the
depth of the channels 34 may be varied to form a central flow diverter 31a as
shown in, e.g.,
FIG. 3E. The flow diverter 31a may comprise a distally-extending projection
(e.g., a
cylindrical projection, a conical projection, a pyramidal projection, etc.)
disposed in a central
region of the bearing between the segments 33. In the illustrated embodiment,
the flow
diverter 31a can comprise a symmetrical flow diverter. The flow diverter 31a
may aid blood
coming from the flow tube or lumen of the shaft 5 to transition from axial
flow to radial flow
to exit through the channels 34. The flow diverter may optionally be
manufactured as one or
more separate pieces that are then attached in the central hollow 31 and/or
channels 34. In
some embodiments, the flow diverter 31a may comprise a generally right
cylindrical shape
extending distally from the bearing 18. In other embodiments, the flow
diverter 31a can have
a tapered, for example, conical, profile.
[0098] The interface between the segments 33 of the conical
member 45 and
concave, e.g., conical, opening 32 of the segmented cone bearing can be
lubricated by blood.
Depending on geometry, materials used, and operating conditions, this
lubrication may be
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hydrodynamic lubrication, elastohydrodynamic lubrication, boundary
lubrication, or mixed
lubrication. The channels 34 between the segments 33 of the conical member 45
of the
bearing pair may promote fluid exchange so that a portion of the blood that
makes up the
lubricating layer between a region of the conical opening 32 of the hearing
pair over one
segment 33 of the conical member of the bearing pair is replaced by fresh
blood in the
lubricating layer that forms between that same region of the conical opening
32 of the
bearing pair and the next segment 33 of the conical member of the bearing pair
during
rotation. The width and depth of the channels 34 can be altered to encourage
this exchange.
In various embodiments, the height and lateral spacing of the segments 33 can
be selected to
provide a desired channel depth and width. For example, a width of the
channels 34 can be
in a range of 0.02" to 0.06", in a range of 0.03" to 0.05", or in a range of
0.035" to 0.045"
(for example, about 0.04" in some embodiments). The surfaces of the segments
33 of conical
member of the bearing pair along the channels 34 form the leading and trailing
edges (as seen
by a region of the conical opening 32 of the bearing pair) of the segments 33
of the conical
member of the bearing pair. The distance of the leading and trailing edges
from the conical
opening 32 may also be modified to encourage fluid exchange. For example, the
edges may
be beveled or rounded or the distance of the leading and trailing edges may
taper away or
towards the surface of the conical opening 32.
[0099] The surfaces of the segments 33 of the conical
member 45 of the bearing
pair may also be modified to diverge from a perfect conical surface to promote
formation of a
lubricating layer. For example, one or more surfaces of the segments 33 of the
conical
member 45 of the bearing pair may be shaped so the normal distance to the
surface of the
conical opening 32 of the bearing pair decreases from the leading edge to the
trailing edge.
Such a surface contour may encourage creation of fluid wedges between the
segments 33 of
the conical member 45 and the conical opening 32 of the bearing pair for
improved
lubrication. In another embodiment. the surfaces of the segments 33 of the
conical member
45 and conical opening 32 of the bearing pair may be smooth and well matched
to allow a
relatively thin lubricating layer of relatively uniform thickness to form. It
should be
appreciated that although conical member 45 and conical opening 32 are
described as having
a generally conical shape in some embodiments, the member 45 and opening 32
may
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generally be considered convex member 45 and concave opening 32. The shapes of
the
convex member and the concave opening 32 may be any suitable mating shapes.
[0100] The flow of blood driven by the secondary impeller 7
from the central
hollow 31 through the channels 34 provides fresh blood for exchange of the
lubricating
layers and carries away heat in the bearing region. Both functions are
important to reducing
the potential for thrombus formation in the segmented cone bearing.
[0101] The segments 33 of the conical member 45 of the
bearing pair and the
conical opening 32 of the bearing pair may each be made of any suitable blood
compatible
bearing material. As a non-limiting example, the segments 33 of the conical
member of the
bearing pair may be made out of titanium or stainless steel and/or the conical
opening 32 of
the bearing pair may be made out of PEEK or polyethylene.
[0102] By making one side of the bearing pair relatively
hard and the other side
of the bearing pair relatively soft, the bearing pair may initially undergo
boundary or mixed
lubrication where surface asperities are worn to the point where the surfaces
of the conical
member and conical opening arc smooth and well-matched enough for hydrodynamic
or
elastohydrodynamic lubrication to dominate. Having one side of the bearing
pair be
relatively softer may increase the range over which elastohydrodynamic
lubrication is
present. In some embodiments, the continuous, conical opening 32 of the
bearing pair will be
softer and the segmented, conical member of the bearing pair will be harder.
This
arrangement may help preserve special geometric features of the segments 33 on
the conical
member of the bearing pair. In some embodiments, the continuous, conical
opening 32 of the
bearing pair will be harder and the segmented, conical member 45 of the
bearing pair will be
softer. This arrangement may help preserve the surface of the opening 32 as a
surface of
rotation about the longitudinal axis L. In other variations the conical
opening 32 and the
conical member 45 can be of similar or even the same hardness which can
provide the
advantage of dimensional and shape stability throughout the operation of the
pump 2.
[0103] In cases where hydrodynamic lubrication dominates,
the normal distance
between the segments 33 on the conical member of the bearing pair and the
conical opening
32 of the bearing pair may be small enough to exclude red blood cells. In
these cases,
exchange of the lubricating layer may be less important as long as heat is
still transferred
away. Given sufficient exclusion of red blood cells, a continuous (e.g.,
without channels or
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grooves) conical member 45 of the bearing pair may still demonstrate low
potential for
thrombus formation as long as heat can be transferred away quickly enough. In
some
embodiments, this may be accomplished by eliminating or covering the channels
34 to form
a continuous conical surface. Blood flow through the covered channels 34 may
transfer
sufficient heat from the bearing pair.
[0104] The segmented bearing embodiments described above
provide an
additional advantage of enhancing the flexibility of the portion of the pump 2
in the vicinity
of the pump head 50. The impeller assembly 4 can be coupled with the drive
unit 9 in a
manner that permits some motion between the impeller assembly 4 and the cover
11. For
example, the pump 2 may be delivered through tortuous or curving vasculature
or may be
inserted from outside the patient to inside a blood vessel in tight bends. The
impeller
assembly 4 can tip toward one or more of the segments 33 and away from one or
more
segments at the conical opening 32 such that proximal end face of the impeller
assembly is at
a non-parallel angle to the distal face of the cover 11. The motion may be
significant
compared to a mounting of the impeller assembly 4 on a shaft rotatably
supported in a drive
unit. The tipping of the impeller assembly 4 can occur with a flexing of the
shroud 16, which
may be flexed in high bending stress maneuvers. In some embodiments, the
shroud 16 is
made of an elastic material, such as nitinol, such that the pump head 50 can
flex and
elastically return to an undeflected state without elongation.
IV. IMPELLER SHAFT WITH FLOW TUBE THROUGH PRIMARY IMPELLER
[0105] FIGS. 4A-5B and 7 illustrate how the flow tube of
the impeller shaft 5
may be routed through the primary impeller 6. This allows for a compact pump
rotor
assembly 46 in which the primary and secondary flow pathways 3A, 3B are
separate and
flow in the same direction through the system 1 as shown in FIGS. 9A-9B.
Having the two
flow paths flow pathways 3A, 3B in the same direction minimizes or reduces the
probability
of blood recirculating through the pump. In some embodiments, the primary
impeller 6 may
also have a thrust ring 14 or thrust surface designed to limit axial motion in
the upstream or
distal direction by contacting a corresponding thrust ring or thrust surface
of the sleeve
bearing 15. The primary impeller 6 may have the features described in U.S.
Pat. Pub. No.
2017/0087288, incorporated by reference herein.
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V. SECONDARY IMPELLER
[0106] As explained herein, the secondary impeller 7 can be
disposed proximal
the primary impeller 6. In some embodiments, as shown in FIGS. 4A-7, the
secondary
impeller 7 can comprise a flange 47 extending non-parallel (e.g., radially
outward along the
radial axis R) from the proximal end portion 5B of the impeller shaft 5 and a
plurality of
vanes 10 on a proximally-facing surface of the flange 47. The flange 47 can
extend non-
parallel and radially outward from the impeller shaft 5. In some embodiments,
the flange 47
may not extend radially beyond the shroud 16. In some embodiments, the flange
47 may not
extend radially beyond an adjacent portion of the impeller assembly 4, e.g.,
may not extend
radially beyond an integrated streamlined fairing 13, discussed below. In some
of these
embodiments, the flange 47 can comprise a section of the combined rotor
surface that lies in
a plane perpendicular to the longitudinal axis L. As shown in FIGS. 4A-4C and
5A, the
vanes 10 can extend proximally from the flange 47 and can have a curved
profile
circumferentially about the longitudinal axis L. The vanes 10 can be disposed
in the space
between the proximal face of the flange 47 and the distal end of the drive
unit 9. The concave
opening 32 can comprise an angled cavity extending inwardly and distally
relative to the
generally proximally-facing surface of the flange 47. The rotor magnet 12 can
be disposed
adjacent a distally-facing surface of the flange 47. Each of the vanes 10 can
have an inner
end 10a disposed at or near the concave opening 32 and an outer end 10b
extending radially
and circumferentially outward from the inner end 10a along the flange 47. The
flange 47 can
be coupled to or formed with the proximal end of the impeller shaft 5. In some
embodiments, for example, the flange 47 can be monolithically formed with
(e.g., seamlessly
formed with) the impeller shaft 5. In other embodiments, the flange 47 and
impeller shaft 5
can be separate components that are mechanically connected to one another
(e.g., welded or
otherwise coupled). In some embodiments, the vanes 10 can be monolithically
formed with
the proximally-facing surface of the flange 47. In other embodiments, the
vanes 10 can be
mechanically connected to the proximally-facing surface of the flange 47.
[0107] As shown in FIG. 4D, the vanes 10 can extend
circumferentially about the
longitudinal axis L in a manner such that adjacent vanes 10 circumferentially
overlap. For
example, the radially outer end 10b of one vane can circumferentially overlap
with, and be
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disposed radially outward from, the radially inner end 10a of an adjacent
vane. The vanes 10
can be prevented from contacting the drive unit 9 by the thrust bearing aspect
of the
segmented cone bearing. As the impeller assembly 4 rotates, the vanes 10 can
pump blood
radially out of the channels 34 in the segmented cone bearing and thereby
increase net flow
through the flow tube of the impeller shaft 5 and segmented cone bearing. As
shown, blood
can exit the flow tube of the impeller shaft 5 at a location proximal the
primary impeller 6
and be driven radially out of the channels 34 by the vanes 10. In the
illustrated embodiment,
five (5) vanes 10 are used, but it should be appreciated that fewer than five
or more than five
vanes 10 can be used.
[0108] As shown in FIGS. 4A, 4C, and 5A, the secondary
impeller 7 can have a
proximal end 52 at a proximal edge of the vanes 10. Further as shown in FIGS.
3A and 3C,
the drive unit 9 can have a distal end 53 at a distal end of the distally-
projecting segments 33.
As explained above, the distally projecting convex segments 33 can be received
within the
concave opening 32 of the rotor assembly 46. When the convex segments 33 are
mated
within the concave opening 32, the distal end 53 of the drive unit 9 is distal
the proximal end
52 of the second impeller 7 (e.g., distal the proximal-most end of the rotor
assembly 46) as
shown, for example, in FIG. 7.
VI. INTEGRATED ROTOR CORE
[0109] As explained herein, in some embodiments the flow
tube of the impeller
shaft 5, the concave opening 32 of the segmented cone bearing, and the
secondary impeller 7
can be integrated into one part as an integrated rotor core 8. Advantages of
this approach
include, without limitation, simpler assembly (as described below) and
minimization or
reduction of joints between parts (particularly on the inner surface of the
flow tube of the
shadft 5). Beneficially, the primary impeller 6 can be disposed on (e.g.,
mounted on and
secured to (e.g., welded to or adhered to)) the impeller shaft 5, which can
provide a compact
design.
[0110] In various embodiments, therefore, the primary
impeller 6 and the impeller
shaft 5 may be separate components, with the impeller 6 mechanically connected
to the
impeller shaft 5. In other embodiments, the primary impeller 6 and impeller
shaft 5 can
comprise a unitary or monolithic structure (e.g., a molded or cast structure).
Such unitary or
monolithic structures can be formed without seams or joints between the
components of the
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unitary or monolithic structure. Similarly, the secondary impeller 7 can be
disposed on (e.g.,
mechanically secured to) the proximal end of the impeller shaft 5. In some
embodiments, the
secondary impeller 7 can be monolithically formed with the impeller shaft 5 so
as to form a
unitary component (e.g., molded, cast, etc.). In other embodiments, the
secondary impeller 7
and the impeller shaft 5 can comprise separate components. In some
embodiments, the
primary impeller 6, the secondary impeller 7 (including the flange 47), and
the impeller shaft
can form a unitary or monolithic component or body. In some embodiments, for
example,
the primary impeller 6, the secondary impeller 7, and the impeller shaft 5 can
be injection
molded over the rotor magnet 12. Where the secondary impeller 5 is molded over
the
magnet 12, the surface on which the secondary impeller 6 is disposed can be
considered a
flange where the surface extends radially outward from a lumen formed in a
central portion
of the molded part. Beneficially, as explained above, the integrated rotor
core 8 can form a
compact structure. Rotation of the drive magnet 17 can impart rotation to the
rotor magnet
12, which is also disposed on (e.g., mechanically connected or mounted on) the
impeller
shaft 5. Rotation of the rotor magnet 12 can impart common rotation to the
impeller shaft 5,
the primary impeller 6, and the secondary impeller 7.
VII. EXAMPLE ASSEMBLED BLOOD FLOW ASSIST SYSTEM
[0111] FIGS. 7 and 8A-8D show an example schematic view
various features of
the blood flow assist system 1 described herein. The features described above
may also be
combined in other ways.
[0112] As shown in FIGS. 7 and 8A, the system 1 comprises
the drive unit 9 with
the motor 30 that can be sealed in the motor housing 29. The drive magnet 17
can be
rotatable by the motor 30 by way of a motor shaft 51. The motor 30 can
electrically connect
to the power wire 20. As shown in FIGS. 8A and 8C, the power wire 20 can
comprise an
insulating body having a central lumen 55 and a plurality of (e.g., three)
outer lumens 56A-
56C extending along a length of the power wire 20. The outer lumens 56A-56C
can be sized
and shaped to receive corresponding electrodes or electrical wire (not shown)
to provide
electrical power to the motor 30. For example, the lumens 56A-56C can receive,
respectively, a hot electrode or wire, a neutral electrode or wire, and a
ground electrode or
wire. The electrodes can extend through corresponding openings 57A-57C of a
motor
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mounting support 54 configured to support the motor 30. The central lumen 55
can be sized
and shaped to receive an elongate stiffening member or guidewire (not shown).
The
stiffening member or guidewire can be inserted into the central lumen 55 to
help guide the
pump 2 to the treatment location. As shown in FIG. 8D, the connector 23 near
the proximal
end 21 of the system 1 can have electrical contacts 58A-58C electrically
connected to the
electrodes in the corresponding outer lumens 56A-56C. The contacts 58A-58C can
comprise
rings spaced apart by an insulating material and can be configured to
electrically connect to
corresponding electrical components in the control system or console (not
shown).
[0113] The drive magnet 17 can be sealed within the drive
unit 9 by the drive unit
cover 11 that may also have features that act as the bearing components(e.g.,
the distally-
projecting segments 33). In some embodiments, the top distal portion of the
cover 11 may
provide the segments 33 forming the conical member 45 of the segmented cone
bearing as
described in this disclosure. The corresponding conical opening 32 of this
bearing pair can be
built into a rotatable piece that comprises the secondary impeller 7 and flow
tube or impeller
shaft 5 (together, the integrated rotor core 8). The convex member 45 matches
the contour
and fits inside of the concave opening 32 of the rotatable piece. The channels
34 in the
segmented cone bearing provide fluid passages for blood entering the bearing
region through
the flow tube 5 and forced out of the bearing region by the secondary impeller
7. A
lubricating layer of blood between the bearing surfaces of the integrated
rotor core 8 and the
matching surfaces of the cone segments 33 provides lubrication, reduces wear,
and eases
relative motion of the two components. Depending on the geometry, rotational
speed, and
materials making up the interface, this may be hydrodynamic,
elastohydrodynamic,
boundary, or mixed lubrication.
[0114] The rotor magnet 12 of the rotor assembly 46 can be
positioned on the
integrated rotor core 8 to be in close proximity to the drive unit 9, thereby
allowing the
integrated rotor core 8 to be magnetically coupled to the drive unit 9 and
rotated as desired.
The first or primary impeller 6 with an integrated streamlined fairing 13 can
be is placed over
the rotor magnet 12 and joined to the integrated rotor core 8 to at least
partially form the
pump rotor assembly 46. The three-piece construction (integrated rotor core 8,
magnet, and
primary impeller 6 with integrated fairing) can have advantages as discussed
previously
related to ease of construction and compact design. In some embodiments, the
portion of the
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primary impeller 6 that interfaces with the flow tube 5 may be shaped to
function as a thrust
pad or to be fit with a separate thrust ring 14 to interface with a matching
thrust pad on the
sleeve bearing 15 that fits around the flow tube 5. The rotor magnet 12 and
primary impeller
6 with the fairing 13 may be secured to the integrated rotor core 8 so that
the components
rotate together.
[0115] Alternatively, the pump rotor could be assembled
from more than three
pieces. In one alternative embodiment, the primary impeller 6 and the fairing
13 are separate
pieces. This can allow the primary impeller 6 and the fairing 13 to be made of
different
materials. Alternatively, the rotor magnet 12 may be coated to be suitable for
blood contact
and may not be covered by the fairing 13, but rather directly joined to the
primary impeller 6.
Such a configuration may allow use of a larger diameter magnet (with
corresponding higher
torque coupling) in the same pump rotor diameter than would be possible with a
magnet
inside a fairing.
[0116] In another alternative embodiment, a separate ring
14 may be added
around the flow tube 5 above the primary impeller 6. This separate ring would
then serve as
the thrust interface that mates with the thrust surface of the sleeve bearing.
The separate ring
could be made of a different material than the flow tube 5 or primary impeller
6.
[0117] The flow tube of the impeller shaft 5 of the pump
rotor can fit inside a
fixed (non-rotating) sleeve bearing 15 (FIG. 7). As explained above, the
sleeve bearing 15
can provide radial confinement of the impeller assembly 4 and the rotor
assembly 46. The
bearing interface comprises the outer surface of the impeller shaft 5 and the
inner surface of
the sleeve bearing 15. The sleeve bearing 15 can have a modified geometry as
explained
above that reduces or minimizes continuous coverage of the outer surface of
the impeller
shaft 5 and thereby reduces the potential for thrombosis. The sleeve bearing
15 may also
optionally provide a thrust bearing surface that interfaces with the optional
thrust bearing
surface of the primary impeller 6 or optional thrust ring 14.
[0118] The outer bearing carrier 38 of the sleeve bearing
15 can attach to the
shroud 16 that fits around the impeller assembly 4 and is attached to the
drive unit cover 11
of the drive unit 9. The connecting structure 39 can include an arm or arms
may attach
directly to the shroud 16 or may attach to a ring that is then attached to the
shroud 16 to
provide improved rigidity and circularity of the shroud 16.
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[0119] The shroud 16 can comprise a tube with an inlet end
and an outlet end.
The shroud 16 can be placed over the various internal components that make up
the pump
rotor (e.g., the impeller assembly 4 and the rotor assembly 46). The outlet
end of the shroud
16 can be secured to the drive unit cover 11 of the drive unit 9. The inlet
side of the shroud
16 can be open to create an inlet port 27. The front bearing is placed within
the inlet port of
the shroud 16 as described above. The outlet side of the shroud 16 has
openings 25 in the
surface of the shroud (outlet ports) that provide outlets for fluid driven by
the primary
impeller 6 and secondary impeller 7.
[0120] While some drawings of the system are shown without
struts for clarity,
the pump may include struts or any other securing means for securing the pump
in the
circulatory system, such as illustrated in U.S. Pat. Nos. 8,012,079 and
9,572,915 and U.S.
Pat. Pub. No. 2017/0087288.
VIII. OPERATION
[0121] As shown in FIGS. 9A and 9B, various embodiments of
the pump 2
provide two flow paths 3A, 3B as explained herein. The first flow pathway 3A
(red in FIGS.
9A-9B) is driven by the primary impeller 6, which draws fluid in through the
inlet port 27 of
the shroud 16 and directs the fluid out of the outlet ports 25 of the shroud
16. The second
flow path 3B (yellow in FIG. 9A and blue in FIG. 9B) is driven by the
secondary impeller 7,
which draws fluid through the internal secondary flow path 3B, e.g., a lumen
or flow tube of
the impeller shaft 5. The internal flow path passes through the flow tube of
the shaft 5 of the
integrated rotor core 8. As the fluid reaches the proximal end 5B of the shaft
5, some of the
fluid passes through the channels 34 between the cone segments 33 and a
smaller fraction
passes between the matching conical surfaces of the bearing interfaces (e.g.,
between the
convex member 45 and the concave opening or cavity 32). The fluid can be
driven radially
outward by the vanes 10 of the secondary impeller 7. Notably, flow from both
flow paths
can be directed from the inlet 27 to the outlet 25 in the illustrated
embodiment. In other
embodiments, as described herein, the flow of blood can be reversed.
[0122] It shall be apparent to one of ordinary skill in the
art that fluid flowing
through the secondary flow path, particularly the fluid layer between the
matching cone
bearing interface surfaces, acts as a lubricating layer between the rotor
assembly 46 and the
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fixed segments 33 of the segmented cone bearing. Further, the matching conical
surfaces of
the segmented cone bearing can provide both axial and radial confinement of
the pump
assembly 46.
IX. ADVANTAGES
[0123]
Various embodiments disclosed herein can have a number of unique
advantages. Many of these advantages are described herein, but they are not an
exhaustive
list. The following are only additional non-limiting examples of advantages,
one or more of
which can apply to particular embodiments.
[0124] a.
Bearing elements (e.g., the sleeve bearing 15, 15A, 15B and/or
the segmented cone bearing) can have surface area contact rather than point
contact
or line contact.
[0125] b.
Secondary flow along the second pathway 3B may be in the
same direction as the primary flow pathway 3A to reduce or to minimize
potential
recirculation of blood.
[0126] c.
The flow tube or shaft 5, conical opening 32 of segmented cone
bearing, and the secondary impeller 7 can be beneficially integrated in an
integrated
rotor core 8.
[0127] d.
Attractive force of the magnetic coupling utilizes a thrust
bearing in only one direction to support the external rotor; no thrust bearing
may be
used to prevent movement of the pump rotor 8 away from the drive unit 9.
[0128]
Embodiments described herein are included to demonstrate particular
aspects of the present disclosure. It should be appreciated by those of
ordinary skill in the art
that the embodiments described herein merely represent non-limiting
embodiments of the
disclosure. Those of ordinary skill in the art should, in light of the present
disclosure,
appreciate that many changes can be made in the specific embodiments
described, including
various combinations of the different elements, components, steps, features,
or the like of the
embodiments described, and still obtain a like or similar result without
departing from the
spirit and scope of the present disclosure. From the foregoing description,
one of ordinary
skill in the art can easily ascertain the essential characteristics of this
disclosure, and without
departing from the spirit and scope thereof, can make various changes and
modifications to
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adapt the disclosure to various usages and conditions. The embodiments
described
hereinabove are meant to be illustrative only and should not be taken as
limiting of the scope
of the disclosure.
[0129]
Conditional language, such as -can," -could," -might," or -may," unless
specifically stated otherwise, or otherwise understood within the context as
used, is generally
intended to convey that certain embodiments include, while other embodiments
do not
include, certain features, elements, and/or steps. Thus, such conditional
language is not
generally intended to imply that features, elements, and/or steps are in any
way required for
one or more embodiments.
[0130]
The terms "comprising,- "including,- "having.- and the like are
synonymous and are used inclusively, in an open-ended fashion, and do not
exclude
additional elements, features, acts, operations, and so forth. Also, the term
"or" is used in its
inclusive sense (and not in its exclusive sense) so that when used, for
example, to connect a
list of elements, the term "or" means one, some, or all of the elements in the
list. In addition,
the articles -a," -an," and -the" as used in this application and the appended
claims are to be
construed to mean "one or more" or "at least one" unless specified otherwise.
[0131]
The ranges disclosed herein also encompass any and all overlap, sub-
ranges, and combinations thereof. Language such as "up to," "at least,"
"greater than," "less
than," "between," and the like includes the number recited. Numbers preceded
by a term
such as "about" or "approximately" include the recited numbers and should be
interpreted
based on the circumstances (e.g., as accurate as reasonably possible under the
circumstances,
for example 5%, 10%, 15%, etc.). For example, "about 1" includes "1."
Phrases
preceded by a term such as "substantially," "generally," and the like include
the recited
phrase and should be interpreted based on the circumstances (e.g., as much as
reasonably
possible under the circumstances).
For example, "substantially spherical" includes
"spherical." Unless stated otherwise, all measurements are at standard
conditions including
temperature and pressure.
[0132]
As used herein, a phrase referring to "at least one of" a list of items
refers
to any combination of those items, including single members. As an example, -
at least one
of: A, B, or C" is intended to cover: A, B, C, A and B, A and C, B and C, and
A, B, and C.
Conjunctive language such as the phrase "at least one of X, Y and Z," unless
specifically
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stated otherwise, is otherwise understood with the context as used in general
to convey that
an item, term, etc. may be at least one of X, Y or Z. Thus, such conjunctive
language is not
generally intended to imply that certain embodiments require at least one of
X, at least one of
Y and at least one of Z to each be present.
[0133] Although certain embodiments and examples have been
described herein,
it should be emphasized that many variations and modifications may be made to
the humeral
head assembly shown and described in the present disclosure, the elements of
which are to be
understood as being differently combined and/or modified to form still further
embodiments
or acceptable examples. All such modifications and variations are intended to
be included
herein within the scope of this disclosure. A wide variety of designs and
approaches are
possible. No feature, structure, or step disclosed herein is essential or
indispensable.
[0134] Some embodiments have been described in connection
with the
accompanying drawings. However, it should be understood that the figures are
not drawn to
scale. Distances, angles, etc. are merely illustrative and do not necessarily
bear an exact
relationship to actual dimensions and layout of the devices illustrated.
Components can be
added, removed, and/or rearranged. Further, the disclosure herein of any
particular feature,
aspect, method, property, characteristic, quality, attribute, element, or the
like in connection
with various embodiments can be used in all other embodiments set forth
herein.
Additionally, it will be recognized that any methods described herein may be
practiced using
any device suitable for performing the recited steps.
[0135] For purposes of this disclosure, certain aspects,
advantages, and novel
features are described herein. It is to be understood that not necessarily all
such advantages
may be achieved in accordance with any particular embodiment. Thus, for
example, those
skilled in the art will recognize that the disclosure may be embodied or
carried out in a
manner that achieves one advantage or a group of advantages as taught herein
without
necessarily achieving other advantages as may be taught or suggested herein.
[0136] Moreover, while illustrative embodiments have been
described herein, it
will be understood by those skilled in the art that the scope of the
inventions extends beyond
the specifically disclosed embodiments to any and all embodiments having
equivalent
elements, modifications, omissions, combinations or sub-combinations of the
specific
features and aspects of the embodiments (e.g., of aspects across various
embodiments),
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adaptations and/or alterations, and uses of the inventions as would be
appreciated by those in
the art based on the present disclosure. The limitations in the claims are to
be interpreted
fairly based on the language employed in the claims and not limited to the
examples
described in the present specification or during the prosecution of the
application, which
examples are to be construed as non-exclusive. Further, the actions of the
disclosed
processes and methods may be modified in any manner, including by reordering
actions
and/or inserting additional actions and/or deleting actions. It is intended,
therefore, that the
specification and examples be considered as illustrative only, with a true
scope and spirit
being indicated by the claims and their full scope of equivalents.
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